Electronic Decision Aid for Atrial Fibrillation

Recruiting at 1 trial location

Overseen By Joel Adekanye, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Dual antiplatelet therapy

Disqualifiers: Valvular AF, Non-AF anticoagulation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to evaluate the utility of a new electronic patient decision aid for stroke prevention therapy in patients with atrial fibrillation. The main questions it aims to answer are: Is the patient decision aid acceptable to both patients and physicians? Does the patient decision aid lead to more effective shared decision-making than standard care among patients with atrial fibrillation who are considering stroke prevention therapy? Participants with a recent diagnosis of atrial fibrillation will be enrolled before an upcoming specialist physician visit. Researchers will compare a pre-visit intervention consisting of standard educational materials plus use of the patient decision aid to educational materials alone to see if using the decision aid results in improved shared decision making during the clinic visit.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, if you are currently on dual antiplatelet therapy for a reason other than atrial fibrillation, you cannot participate.

What data supports the effectiveness of the electronic patient decision aid treatment for atrial fibrillation?

Research shows that decision aids can help patients with atrial fibrillation make better treatment choices by improving their understanding and aligning care with their preferences, which can lead to better adherence to treatment and potentially reduce the risk of stroke. ^{1 2 3 4 5}

Is the electronic decision aid for atrial fibrillation safe for humans?

The research does not provide specific safety data for the electronic decision aid itself, but it is designed to help patients make informed decisions about their treatment options, which are generally safe when used as directed. ^{2 5 6 7 8}

How is the electronic decision aid treatment for atrial fibrillation different from other treatments?

The electronic decision aid for atrial fibrillation is unique because it helps patients make informed decisions about their treatment options by providing interactive visualizations and supporting shared decision-making with their healthcare team, rather than directly treating the condition itself. ^{2 5 7 9 10}

Research Team

Stephen B Wilton, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults over 18 who were diagnosed with non-valvular atrial fibrillation within the last year. They can have any level of stroke risk and either be new to oral anticoagulant therapy or treated for less than three months. Participants must have a specialist visit scheduled within the next 7-30 days.

Inclusion Criteria

I have an appointment with a heart specialist between 7 to 30 days from now.

I was diagnosed with non-valvular AF less than a year ago.

I have not been on blood thinners, or was on them for less than 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive either the RAPID AFib decision aid or standard educational materials before their clinic visit

1 week

1 visit (in-person)

Clinic Visit

Participants attend a clinic visit where shared decision-making is assessed

1 day

1 visit (in-person)

Follow-up

Study participation ends after completion of a post-visit survey to assess shared decision-making and therapy decisions

Immediately after clinic visit

Treatment Details

Interventions

• Electronic patient decision aid

Trial Overview Researchers are testing an electronic decision aid designed to help patients with atrial fibrillation make informed choices about stroke prevention therapy. The study compares outcomes from using this tool plus standard educational materials against just educational materials before a doctor's visit.

Participant Groups

Group I: Patient Decision Aid Experimental Treatment 1 Intervention

Receives web-based information and access to patient decision aid before clinic visit

Group II: Control Active Control 1 Intervention

Receives web-based information only before clinic visit

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Servier

Industry Sponsor

Trials

55

Recruited

45,600+

Findings from Research

The ENHANCE-AF trial is a multicenter, randomized controlled study involving 1,200 participants aimed at evaluating a new decision aid for shared decision making (SDM) in anticoagulation therapy for patients with atrial fibrillation (AF).

The primary outcome is to assess the Decisional Conflict Scale one month after the decision-making visit, with secondary outcomes including patient and clinician satisfaction, adherence to anticoagulation, and rates of major bleeding, death, stroke, or transient ischemic attack over a 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design. Baykaner, T., Pundi, K., Lin, B., et al.[2022]

An interactive decision-making aid was developed for patients with atrial fibrillation (AF) using a user-centered design approach, incorporating feedback from both experts and AF patients.

Preliminary evaluations suggest that this decision aid, which includes visualizations, could effectively help patients make informed treatment decisions regarding their AF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing for patient decision-making: Design challenges generated by patients with atrial fibrillation during evaluation of a decision aid prototype. Fanio, J., Zeng, E., Wang, B., et al.[2023]

Decision aids (DAs) significantly reduce decisional conflict regarding the use of oral anticoagulants (OACs) and enhance their uptake among patients with atrial fibrillation (AF), based on a meta-analysis of 10 studies.

DAs that incorporate key elements of shared decision-making, such as clarifying options and aligning with patient preferences, are more effective in promoting OAC uptake, although their impact on adherence and the incidence of stroke and bleeding remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision aids for shared decision-making and appropriate anticoagulation therapy in patients with atrial fibrillation: a systematic review and meta-analysis. Song, D., Zhou, J., Fan, T., et al.[2022]

A review of 7 studies found that decision aids for stroke prevention in atrial fibrillation significantly improved patient knowledge and involvement in treatment choices, while also reducing decisional conflict.

Despite their effectiveness, none of the evaluated decision aids are currently accessible for clinical use, highlighting a gap in resources that could help patients make informed choices about their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability of patient decision aids for stroke prevention in atrial fibrillation: A systematic review. O'Neill, ES., Grande, SW., Sherman, A., et al.[2018]

A study involving 15 patients with atrial fibrillation and 5 clinicians revealed that while patients experienced low decisional conflict and regret regarding catheter ablation, they felt under-informed and lacked agency in the decision-making process.

Patients expressed a strong preference for an interactive, web-based decision aid that provides clear evidence and personalized risk assessments, indicating a need for tools that enhance decision quality and patient engagement in treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Replace uncertainty with information': shared decision-making and decision quality surrounding catheter ablation for atrial fibrillation. Reading Turchioe, M., Mangal, S., Ancker, JS., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Designing for patient decision-making: Design challenges generated by patients with atrial fibrillation during evaluation of a decision aid prototype. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Decision aids for shared decision-making and appropriate anticoagulation therapy in patients with atrial fibrillation: a systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Availability of patient decision aids for stroke prevention in atrial fibrillation: A systematic review. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Development and description of a decision analysis based decision support tool for stroke prevention in atrial fibrillation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Effect of a Patient Decision Aid for Atrial Fibrillation Stroke Prevention Therapy. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Application of a decision support tool for anticoagulation in patients with non-valvular atrial fibrillation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of Computerized Decision Support Systems on Management of Atrial Fibrillation: A Scoping Review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

'Replace uncertainty with information': shared decision-making and decision quality surrounding catheter ablation for atrial fibrillation. [2023]